Collaborative Care for Polysubstance Use in Primary Care Settings (Co-Care)

NCT06116266 | Recruiting DMC

• 2 other identifiers: 23-01169UG1DA013035
• Study Type: interventional
• Target: 350
• Locations: 1 country
• Sites: 8

Brief Summary

The purpose of this trial is to test the efficacy of a collaborative care intervention to address opioid- and/or stimulant-involved polysubstance use in adult primary care patients with moderate to severe substance use disorders (SUD). The primary aims are to reduce days of opioid use (illicit or nonmedical opioid use), days of illicit stimulant use (cocaine, methamphetamine), and days of heavy alcohol use.

Conditions

Substance Use

Outcome Measures

Primary Outcomes (1)

• Total days of use of opioids, stimulants, and alcohol heavy drinking

  Days of opioid use are defined as days with any use of heroin or synthetic opioids, or nonmedical use of prescription opioids. Nonmedical use includes using prescription opioids more than prescribed (e.g., taking two tablets when the prescription indicates a dose of one tablet) or taking pharmaceutical opioids that were not prescribed to the individual taking them. Days of stimulant use are defined as days with any use of cocaine or methamphetamine. Days of alcohol heavy drinking are defined as days with 5+ drinks/day for men, 4+ drinks/day for women. This outcome measure is collected using single item questions based on the Addiction Severity Index. Patient participants are asked to specify the number of days of use in the past 30 days (range is 0-30 days, value=0 for substances that were not used). The assessment is self-administered using a computerized form.

  Month 4-6

Secondary Outcomes (68)

• Treatment Effectiveness Assessment (TEA) total score

  Baseline

• Treatment Effectiveness Assessment (TEA) total score

  Month 3

• Treatment Effectiveness Assessment (TEA) total score

  Month 6

• Treatment Effectiveness Assessment (TEA) total score

  Month 12

• Total days of use of opioids, stimulants, and alcohol

  Months 10-12

Study Arms (2)

Co-Care

EXPERIMENTAL

Patient participants with providers will receive primary care treatment plus the full Co-Care intervention which includes: Nurse Care Manager (NCM) visits, Addiction specialist consultations through NCM if indicated, and Health coaching sessions.

Other: Education and support for primary care providers (PCPS); Other: Nurse Care Manager (NCM) visits; Other: Addiction specialist consultant; Other: Health coaching sessions

Enhanced Usual Care (EUC)

ACTIVE COMPARATOR

Patient participants with providers will receive primary care treatment as usual plus educational materials.

Other: Education and support for primary care providers (PCPS); Other: Patient educational materials

Interventions

Addiction specialist consultant OTHER

An addiction specialist consultant who supports the nurse care manager and PCP in formulating and adjusting treatment plans

Co-Care

Health coaching sessions OTHER

Health coaches who use motivational interviewing and cognitive behavioral therapy to motivate and support patients in behavior change to reduce polysubstance use-related harms. Patients may receive up to 12 health coaching sessions in total. The sessions will occur via phone and/or HIPAA compliant video chat software.

Co-Care

Patient educational materials OTHER

Patient participants receive an educational pamphlet addressing overdose prevention, information about accessing naloxone, and local SUD treatment options.

Enhanced Usual Care (EUC)

Education and support for primary care providers (PCPS) OTHER

All PCPs in the EUC and Co-Care arms receive brief education on SUD treatment, including medications for OUD and AUD and contingency management for StUD, and recognizing and counteracting stigma while caring for patients with SUD.

Co-Care; Enhanced Usual Care (EUC)

Nurse Care Manager (NCM) visits OTHER

A full-time clinic-embedded nurse care manager who works with patients and their PCPs to facilitate and support patient engagement in evidence-based treatment for polysubstance use and management of associated health conditions

Co-Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Licensed medical professional (MD, DO, NP, PA) who is able to prescribe controlled substances (Schedule III), or medical trainee meeting the requirements below.
• Serves as a primary care provider to adult patients (18 years of age and over) of the study clinic(s) during direct patient care sessions.
• Willing to be randomized to either of the study conditions. a. Medical trainees (physicians who are residents or fellows), are eligible if they have at least one continuity clinic session per week on average in the study clinic. Trainees must have plans to be working in a study clinic for approximately 8 months or longer. They must be able to provide prescriptions for controlled substances (Schedule III) either directly or through their preceptor(s).
• The participant's PCP is enrolled in the study.
• Age 18 years or older.
• Spoken and written proficiency in language of study materials, as determined by patient self-report and research staff evaluation.
• Moderate to severe substance use disorder for opioids, stimulants, and/or alcohol, (defined as meeting four or more DSM-5 criteria per substance as measured on the CIDI-adapted for DSM-5).
• a) Patients having alcohol use disorder without an opioid or stimulant SUD are required to have current opioid or stimulant use, as measured on the TAPS tool or baseline monthly survey.
• Current polysubstance use, defined as self-reported use of two or more substances of concern in the past 30 days, at least one of which is required to be an opioid or stimulant. Substances of concern include opioids (illicit opioids, nonmedical use of prescription opioids), stimulants (cocaine, methamphetamine), alcohol (heavy drinking defined as more than 5 for men and 4 for women drinks on a single occasion), and benzodiazepines (nonmedical use). Nonmedical use includes using prescription medications more than prescribed, or that were not prescribed to the individual taking them.
• Patients must report on the baseline monthly survey use in the past 30 days of at least one substance at or above the following thresholds: \>10 days for opioids; \>10 days for alcohol heavy drinking; \>7 days for stimulants. These minimum thresholds reflect levels of use that are typical for individuals with moderate to severe SUD, and are lower for stimulants than for opioids and alcohol to reflect the different patterns of use that are observed in prior trials.
• Access to a reliable cell phone or willing to accept a phone as part of the incentive for completing the baseline visit (as determined by patient self-report).
• Able to provide sufficient contact information (minimum of one locator).
• Willing and able to provide written informed consent.

You may not qualify if:

• Definite plan to resign from the clinic in the next eight months, per PCP self-report. Residents and fellows will need at least eight months before training completion to enroll.
• Currently being treated with medication for OUD (MOUD), and do not have moderate to severe AUD or StUD
• Initiated MOUD treatment (buprenorphine, methadone, or XR-NTX) within the 30 days prior to screening, per patient self-report. Because substance use may fall rapidly with the initiation of MOUD, patients who recently started MOUD may already be in the process of making changes to their substance use that are not attributable to the intervention.
• a) Initiation is defined as starting a new MOUD treatment episode, after not receiving MOUD treatment in the prior 30 days
• Initiated a SUD treatment program within the 30 days prior to screening, per patient self-report. Because substance use may fall rapidly with the initiation of a treatment program, patients who recently initiated treatment may already be making changes to their substance use that are not attributable to the intervention. SUD treatment program includes outpatient or residential programs for alcohol/drug treatment; does not include detox or short-term inpatient episodes (\<15 days), or peer support (e.g., 12-Step Program such as AA/NA, Smart Recovery)
• a) Initiation is defined as starting a new treatment episode, after not being in a SUD treatment program in the prior 30 days
• Pregnancy, as determined by patient self-report.
• Are currently in jail, prison, or other overnight facility as required by court of law or have pending legal action that could prevent participation in study activities
• Definite plan to leave the area or the clinical practice within the next six months, per patient self-report.
• Other factors that may cause harm or increased risk to the participant or close contacts or preclude the patient's full adherence with or completion of the study (e.g. unstable/severe acute mental illness).

Sponsors & Collaborators

• NYU Langone Health: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (8)

Harbor-UCLA Medical Center

Torrance, California, 90502, United States

RECRUITING

NYU Langone Health

New York, New York, 10016, United States

ACTIVE NOT RECRUITING

The Institute for Family Health

New York, New York, 10025, United States

RECRUITING

Winding Waters Medical Clinic

Enterprise, Oregon, 97828, United States

RECRUITING

Union Community Care

Lancaster, Pennsylvania, 17603, United States

RECRUITING

Harris Health

Houston, Texas, 77030, United States

RECRUITING

Sea Mar Community Health Centers

Bellingham, Washington, 98226, United States

ACTIVE NOT RECRUITING

Wisconsin Research & Education Network

Madison, Wisconsin, 53705, United States

RECRUITING

MeSH Terms

Conditions

Substance-Related Disorders

Interventions

Educational Status; Palliative Care

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Jennifer McNeely, MD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rebecca Stone, MPH

CONTACT

Rebecca.stone@nyulangone.org

Noa Appleton, MPH

CONTACT

Noa.Appleton@nyulangone.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2023
• First Posted: November 3, 2023
• Study Start: January 31, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): February 1, 2027
• Last Updated: February 6, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
• Access Criteria: Anyone who wishes to access the data for any purpose can find that data is available indefinitely at (https://datashare.nida.nih.gov/).

Locations

US (8)